whitepaper
Q&A: Strengthen your pharma analysis and QC expertise
Facing challenges with your small or large molecules analysis & QC? Interested to learn from your industry peers? Ask us any question.
List view / Grid view
Regulation & Legislation
news
UK government secures early access to 90 million doses of COVID-19 vaccines
The government has entered partnerships with Pfizer and Valneva to secure doses of several promising COVID-19 vaccines and secured COVID-19 neutralising antibody treatments from AstraZeneca.
article
Trademarks in the medical sphere: practice, examination and obstacles for registration in Russia, Ukraine and the CIS
Dr Tatiana Lipovaya and Alyona Chernoknyzhnaya discuss some of the main considerations when applying for trademarks in the pharmaceutical industry in Russia, Ukraine and the CIS.
whitepaper
Whitepaper: GMP Cleanroom Environmental Monitoring
This whitepaper from Beckman Coulter explores GMP cleanroom routine environmental monitoring and data integrity.
news
FDA grants Fast Track designation to two COVID-19 vaccines
Two investigational SARS-CoV-2 vaccine candidates, BNT162b1 and BNT162b2, currently in clinical trials have been granted Fast Track designation by the FDA.
news
NICE recommends Adcetris (brentuximab vedotin) for treatment of rare lymphoma
The recommendation of Adcetris (brentuximab vedotin) represents the first new frontline therapy for systemic anaplastic large cell lymphoma (sALCL) in several decades.
article
FMD alerts in 2020 – where we are a year into legislation
Over a year since the EU FMD came into force, false alerts remain a problem preventing the realisation of the full benefits of the directive. Grant Courtney examines the reasons behind these alerts occurring and looks at the action stakeholders must now take.
news
EMA issues opinion on nitrosamines in medicines
The agency’s opinion will require companies to take measures to reduce nitrosamine impurities in medicines and carry out and action the results of risk assessments.
news
Cervical dysplasia treatment device approved for global Phase III trial
The cervical dysplasia drug-device product, APL-1702 (Cevira®), offers an alternative to surgery and has been approved to start a clinical trial in China and several other countries.
news
India approves remdesivir for restricted emergency use in COVID-19 patients
The Drug Controller General of India (DCGI) approved remdesivir lyophilised powder for emergency use in patients hospitalised with severe COVID-19.
news
Expanded access for compassionate use of remestemcel-L in COVID-19 infected children
US expands access to remestemcel-L for compassionate use in COVID-19 infected children with complications of multisystem inflammatory syndrome.
article
How to start up an ATMP clinical trial
Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues or cells. They offer revolutionary opportunities for the treatment of disease and injury; however, developers face a complex regulatory and developmental landscape to bring ATMPs to market. Here Magdalena Czarnecka offers guidance and advice on effectively initiating an ATMP…
news
FDA approves new heart rhythm devices featuring Bluetooth connectivity and continuous remote monitoring
Abbott’s Gallant™ implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices are given approval.
news
EMA recommends Idefirix (imlinfidase) is granted marketing authorisation
The European Medicines Agency (EMA) recommended Idefirix is granted conditional marketing authorisation for highly sensitised patients awaiting kidney transplant.
news
CHMP recommends cystic fibrosis treatment Kaftrio is granted marketing authorisation
The European Medicines Agency's human medicines committee (CHMP) said the treatment would offer a therapeutic option for certain cystic fibrosis phenotypes that are currently untreatable.
